Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Fetal Growth Restriction Clinical Trial

Official title:

Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177824
• Other study ID #: 123sc
• Status: Recruiting
• Phase: Phase 3
• First received: April 26, 2017
• Last updated: June 8, 2017
• Start date: March 30, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: June 2017
• Source: Ain Shams University
• Contact: shaimaa mohamed Ezz el Din, MB ChB
• Phone: +201000484298
• Email: dr.shaimaaezz666[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Maternal age ranging from 20-40 years.

• Gestational age 28-37 weeks.

Exclusion Criteria:

• Obese patients (BMI >30 kg/m2).

• Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.

• Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.

• Fetal distress.

• Pregnancy of multiple fetuses.

• Congenital fetal malformation or chromosomal abnormalities.

• Diastolic blood pressure more than 110 mmHg.

• Hypersensitivity to the drug.

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation

Intervention

Drug:
• Sildenafil Citrate 25Mg Tab
Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
• Placebo Oral Tablet
Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score

Locations

Country	Name	City	State
Egypt	Ain Shams matrnity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	date of delivery after Sildenafil citrate administration.	the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.	for 6 months from the beginning of the study
Secondary	Expected fetal weight by serial ultrasound after Sildenafil citrate administration	the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .	every two weeks after drug intake for 6 months from the beginning of the study
Secondary	Color Doppler changes on umbilical artery	Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .	weekly after drug intake for 6 months from the beginning of the study
Secondary	neonatal outcomes as regard birth weight	the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.	for 6 months from the beginning of the study
Secondary	neonatal outcomes as regard APGAR score	the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.	for 6 months from the beginning of the study